Bard Marquee Biopsy Instruments Recalled for Potential Needle Detachment
Bard Peripheral Vascular Inc. is recalling Bard Marquee Disposable Core Biopsy Instrument Kits due to a manufacturing defect where some units lack a needle retention feature, risking detachment during use and potential tissue damage or bleeding.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves a manufacturing defect that creates risk of serious harm (tissue damage and bleeding from needle detachment during a medical procedure). However, no injuries or hospitalizations have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
Bard Peripheral Vascular Inc. is recalling approximately 71,498 Bard Marquee Disposable Core Biopsy Instrument Kits because some units were potentially manufactured without a backend notch retention feature on the needle. This missing feature could result in inadequate securing of the needle inside the device.
If the needle is not properly secured, it could detach and become misplaced during a biopsy procedure, potentially leading to tissue damage and bleeding. The affected products include four product variants with multiple lot numbers and expiration dates ranging from September 2025 through July 2028.
The affected products have been distributed worldwide, including throughout the United States and to multiple international locations. Healthcare facilities and medical professionals who use these devices should verify whether affected lots are in their inventory and discontinue use of affected units immediately.
Patients who have undergone biopsy procedures using these instruments should contact their healthcare provider if they experience unusual bleeding or symptoms suggesting tissue injury.
The recalled product
- Product
- Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G X 13 CM, REF: MQ1213
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 71,498
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- REF/UDI-DI/Lot(Expiration): MQK1210/00801741097263/1490758(9/28/2025)
- 1506044(1/28/2026)
- 1506045(1/28/2026)
- 1511827(2/28/2026)
- 1514692(3/28/2026)
- 1518977(4/28/2026)
- 1518978(4/28/2026)
- 1518979(4/28/2026)
- 1519143(4/28/2026)
- 1520507(5/28/2026)
- 1520508(5/28/2026)
- 1522157(5/28/2026)
- 1522158(5/28/2026)
- 1522577(5/28/2026)
- 1523785(6/28/2026)
- 1523914(6/28/2026)
- 1523915(6/28/2026)
- 1525370(6/28/2026)
- 1525371(6/28/2026)
- 1525373(6/28/2026)
Distribution
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